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The Datex-Ohmeda BIS module, M-BIS and accessories are indicated for monitoring the state of the brain by data acquisition of electroencephalograph (EEG) signals of all hospitalized patients. The Bispectral index (BIS), a processed EEG variable, may be used as an aid in monitoring the effects of certain anesthetic agents. The device is indicated for use by qualified medical personnel only.

The Datex-Ohmeda BIS module, M-BIS is a single-width plug-in parameter module for a Datex-Ohmeda modular monitoring system. The Datex-Ohmeda BIS module, M-BIS can be used with the following Datex-Ohmeda modular monitors: S/5 Anesthesia Monitor (AM), S/5 Compact Anesthesia Monitor (CAM), S/5 Critical Care Monitor (CCM) and S/5 Compact Critical Care Monitor (CCCM) with main software L-ANE02(A)... 00 or L-ICU02(A)... 00 or newer version. The Datex-Ohmeda BIS module M-BIS, and accessories is a parameter module for monitoring the state of the brain by data acquisition of EEG signals of all hospitalized patients. The BIS, a processed EEG variable, may be used as an aid in monitoring the effects of certain anesthetic agents. The accessories: The Datex-Ohmeda BIS module, M-BIS is used in conjunction with Aspect Medical Systems, Digital Signal Converter-Expanded Performance, DSC-XP (KOI 1534), Patient Interface Cable; PIC (KOI 1534), and BIS Sensor Plus (K994330), BIS Sensor XP (K002734) or BIS Sensor Pediatric (K001980). The raw EEG signal can be displayed from one of the two monitored channels. The waveform size, color and sweep speed can be adjusted. Calculated parameters are: Bispectral Index,BIS(Range=0-100),continuous processed EEG parameter correlating to the patient's level of hypnosis, where 100=awake and 0=comatose. Suppression Ratio.SR.(Range=0-100%), the percentage of evochs in the past 63 seconds in which the EEG signal is considered suppressed. Electromyograph, EMG, the absolute power (in decibels) in the frequency range 70-110 Hz Signal Quality Index, SQI (Range:0-100%), the percentage of good epochs in the last 60sec. that could be used to calculate the Bispectral Index and spectral variables. All the calculated parameters can be selected on the display, and trended. Alarms for BIS are taken care of by the host monitor and follow the user interface for alarms in Datex-Ohmeda S/5 patient monitors. There are auditory and visual alarms and user adjustable limits for BIS. The default is OFF, because it doesn't provide information to be used for treatment or therapy. The BIS Engine at BIS module dictates error messages displayed at Datex-Ohmeda's host monitor's message fields and service page. These error messages are related to the BIS measurement, but follow Datex-Ohmeda user interface rules.

The provided text describes a 510(k) premarket notification for the Datex-Ohmeda S/5 BIS Module, M-BIS, and accessories. This submission focuses on establishing substantial equivalence to a predicate device (Aspect Medical Systems Inc. BIS Engine K011534) rather than presenting a de novo study with specific acceptance criteria and performance data for a new, unique device.

Therefore, the document does not contain a table of acceptance criteria or a study proving the device meets those criteria in the way a clinical trial for a novel device would.

Instead, the submission demonstrates equivalence by stating:

• Identical fundamental technology: The BIS engine technology (hardware and software) is identical to the predicate.
• Same basic functions, operating principles, and signal processing: These are described as being the same as the predicate.
• Identical parameters: Raw EEG, processed EEG variables (BIS Index, Suppression Ratio, Electromyograph, Signal Quality Index), and electrode impedance information are supplied by the same BIS Engine as the predicate.
• Identical user features: Multiple BIS smoothing rates, update rates, and various filters are available and identical to the predicate.
• Identical accessories: Uses the same DSC-XP, PIC Plus, and BIS Sensors as the predicate.
• Compliance with safety standards: The device complies with numerous electrical safety, electromagnetic compatibility, mechanical, environmental, and software validation standards, as listed.

Based on the provided text, the following information is NOT available and would typically be found in a study proving acceptance criteria for a novel device:

1. A table of acceptance criteria and the reported device performance: This document doesn't define specific performance metrics with acceptance thresholds (e.g., accuracy, sensitivity, specificity, or correlation coefficients with specific targets) for the M-BIS module, nor does it report the results of a study against such criteria. Its entire premise is that the core technology is identical to a previously cleared device.
2. Sample size used for the test set and the data provenance: Not applicable as no new clinical performance study is described for the M-BIS module's core function. The core technology is considered identical to the predicate.
3. Number of experts used to establish the ground truth for the test set and qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a measurement module for physiological signals, not an AI diagnostic tool involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document states the "BIS engine technology (Hardware and Software) are identical compared to the predicate," implying that the core algorithm performance is already established through the predicate. It doesn't describe new standalone testing for this specific submission's purpose.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to this type of submission. The ground truth for the predicate device would have been established previously, likely through correlation with clinical observations of anesthetic depth.
8. The sample size for the training set: Not applicable, as no new algorithm development or training is described. The algorithm is stated to be identical to the predicate.
9. How the ground truth for the training set was established: Not applicable.

In summary:

This 510(k) submission focuses on demonstrating substantial equivalence to a predicate device by asserting that the underlying technology, functions, accessories, and core algorithms are identical. It relies on the pre-existing clearance and validation of the predicate device (Aspect Medical Systems Inc. BIS Engine K011534) for its safety and effectiveness claims. Therefore, the document does not detail a new study with explicit acceptance criteria and corresponding performance data for the M-BIS module itself, as would be expected for an entirely novel device or a de novo submission.

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